Nchi: Ayalandi
Lugha: Kiingereza
Chanzo: HPRA (Health Products Regulatory Authority)
Caffeine; Paracetamol
Haleon Ireland Limited
N02BE; N02BE51
Caffeine; Paracetamol
500/32 milligram(s)
Capsule, hard
Anilides; paracetamol, combinations excl. psycholeptics
Marketed
1982-12-23
PARAEZE HARD CAPSULES Paracetamol 500mg Caffeine 32mg PACKAGE LEAFLET: INFORMATION FOR THE USER The full name of this medicine as listed above has been abbreviated throughout the leaflet for ease of reference to ‘Paraeze’. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always take this medicine exactly as described in the leaflet or as your doctor or pharmacist told you. Keep this leaflet. You may need to read it again. Ask your pharmacist if you need more information or advice. IF YOU GET ANY SIDE EFFECTS, TALK TO YOUR DOCTOR, PHARMACIST OR NURSE. THIS INCLUDES ANY POSSIBLE SIDE EFFECTS NOT LISTED IN THIS LEAFLET. SEE SECTION 4. YOU MUST SEE A DOCTOR IF YOUR SYMPTOMS WORSEN OR DO NOT IMPROVE AFTER 3 DAYS IN THIS LEAFLET: 1. WHAT PARAEZE IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PARAEZE 3. HOW TO TAKE PARAEZE 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE PARAEZE 6. CONTENT OF THE PACK AND OTHER INFORMATION 1. WHAT PARAEZE IS AND WHAT IT IS USED FOR Each capsule contains paracetamol 500 mg and caffeine 32 mg. Paracetamol works by relieving pain and reducing high temperatures. The capsules are for the treatment of the symptoms of mild to moderate pain, such as, SYMPTOMS OF INFLUENZA, FEVERISHNESS AND COLDS, HEADACHE, PERIOD PAINS, MIGRAINE, RHEUMATIC ACHES, NEURALGIA, TOOTHACHE, SORE THROAT, BACKACHE, MUSCLE PAIN. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PARAEZE Please read the following information. This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially "Sodium free". DO NOT TAKE IF YOU: • are allergic to paracetamol, caffeine or any of the other ingredients listed in the leaflet. • are under 12 years of age. TAKE SPECIAL CARE AND TALK TO A PHARMACIST OR YOUR DOCTOR BEFORE TAKING THIS MEDICINE IF YOU: • suffer from kidney or liver problems particularly if you have alcoholic liver disease as the hazards of overdose are greater. • are underweight (weigh less than 50 kg Soma hati kamili
Health Products Regulatory Authority 09 January 2024 CRN00DRWY Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Paraeze Hard Capsules Paracetamol 500mg Caffeine 32mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Active Ingredients: Paracetamol 500 mg. Caffeine 32.0 mg. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsule, hard (capsule) Size 0, hard gelatin capsules with an opaque blue cap and an opaque yellow body, imprinted on both sections with 500/32, containing a white, free flowing granule mix. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS As an analgesic and antipyretic agent. The capsules are recommended for use in the short term management of headaches, migraine and tension headaches, backache, rheumatic pain, muscle pain, period pain, neuralgia, toothache and for relieving fever, aches and pains of colds and influenza including the pain of sore throat. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Adults Only: 1 to 2 capsules which may be repeated 4 hourly as necessary. A maximum of 8 capsules in any 24 hour period. Adolescents aged 12 to 15 years: 1 capsule which may be repeated every 4 to 6 hours. A maximum of 4 doses in any given 24 hour period. Children: Not recommended in children under 12 years of age. Method of Administration: Oral. The lowest dose necessary to achieve efficacy should be used for the shortest duration of treatment. 4.3 CONTRAINDICATIONS Use in children under 12 years. Hypersensitivity to any of the active substances or to any of the excipients. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Paracetamol should be administered with caution under the following circumstances: Hepatic impairment Chronic alcoholism Renal impairment (GFR≤50ml/min) Gilbert's Syndrome (familial non-haemolytic jaundice) Concomitant treatment with medicinal products affecting hepatic function Glucose-6-phosphate dehydrogenase deficiency Health Products Regulatory Authority 09 January 2024 CRN00DRWY Page 2 of 6 Soma hati kamili